Combined Mitral and Tricuspid Versus Isolated Mitral Transcatheter Edge-to-Edge Repair for Mitral Regurgitation With Tricuspid Regurgitation (DUAL-TEER Trial)

Inclusion criteria

General Inclusion Criteria

• Age ≥ 18 years
• Moderate-to-severe or severe (≥3+) degenerative mitral regurgitation (DMR) or functional mitral regurgitation (FMR) combined with severe (≥3+) functional tricuspid regurgitation (FTR)
• New York Heart Association (NYHA) functional class II, III, or IVa
• Anatomically suitable for transcatheter edge-to-edge repair, as assessed by the Heart Team
• Willing and able to comply with the protocol requirements and data collection procedures
• Capable of understanding the purpose of the trial and voluntarily providing written informed consent, either personally or via a legally authorized representative DMR Inclusion Criteria
• Symptomatic moderate-to-severe or severe degenerative mitral regurgitation (MR ≥3+)
• High surgical risk FMR Inclusion Criteria
• Symptomatic moderate-to-severe or severe functional mitral regurgitation (MR ≥3+)

For ventricular FMR:

• Left ventricular ejection fraction (LVEF) < 50%
• Persistent symptoms despite optimized guideline-directed medical therapy (GDMT) and cardiac resynchronization therapy (CRT), if indicated
• Clinically stable for at least 30 days prior to enrollment

For atrial FMR:

• Unsuitable for surgery
• Persistent symptoms despite optimized medical therapy
• Clinically stable for at least 30 days prior to enrollment TR Inclusion Criteria
• Severe functional tricuspid regurgitation (TR ≥3+)
• Persistent symptoms despite guideline-directed medical therapy (GDMT)
• Clinically stable for at least 30 days prior to enrollment

Exclusion criteria

• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure (except dilated cardiomyopathy of ischemic or non-ischemic etiology)
• Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)
• Refractory heart failure requiring advanced therapies (e.g., left ventricular assist device or heart transplantation)
• Left ventricular end-systolic diameter (LVESD) > 70 mm
• Left ventricular ejection fraction (LVEF) ≤ 20%
• Pulmonary arterial hypertension as assessed by right heart catheterization (RHC)
• Severe right ventricular dysfunction, defined as:

Tricuspid annular plane systolic excursion (TAPSE) < 10 mm, or Right ventricular tissue Doppler imaging S' < 6 cm/s, or Fractional area change (FAC) ≤ 22%

-Hemodynamic instability, defined as: Systolic blood pressure < 90 mmHg with afterload reduction, or Cardiogenic shock requiring inotropic support, intra-aortic balloon pump, or ther mechanical circulatory support

• Severe uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg)
• Myocardial infarction or unstable angina within 30 days prior to enrollment
• Significant untreated coronary artery disease requiring revascularization, or coronary intervention performed within 30 days prior to enrollment
• Moderate or greater aortic valve or pulmonary valve stenosis or regurgitation Mitral valve anatomy deemed unfavorable for transcatheter edge-to-edge repair by the Heart Team, including:Moderate-to-severe calcification in the grasping zone; Mitral valve orifice area < 3.5 cm²; Posterior mitral leaflet length < 7 mm; Mitral stenosis; Leaflet perforation; Multi-segment disease or multiple chordal rupture Tricuspid valve anatomy deemed unfavorable for transcatheter edge-to-edge repair by the Heart Team, including:Moderate-to-severe calcification in the grasping zone; Coaptation gap ≥ 10 mm; Severe leaflet perforation, cleft lesions, or other conditions preventing device implantation
• Congenital Ebstein's anomaly
• Prior surgical or interventional procedure involving the mitral or tricuspid valve
• Pacemaker or implantable cardioverter-defibrillator (ICD) leads interfering with proper device positioning
• Intracardiac thrombus, vegetation, mass, or tumor in the atria or ventricles
• Cerebrovascular accident (stroke) within 3 months prior to enrollment
• Chronic obstructive pulmonary disease requiring continuous home oxygen therapy or long-term outpatient oral steroid treatment
• End-stage renal disease requiring chronic dialysis
• Vascular access limitations, including inferior vena cava filter, severely tortuous or obstructed caval system, or difficult transseptal puncture
• Contraindications to antithrombotic therapy, or history of intracerebral hemorrhage, gastrointestinal bleeding, or bleeding disorders within 3 months prior to enrollment
• Uncontrolled active infection, including active bacterial endocarditis
• Severe comorbidities that may complicate treatment evaluation (e.g., coma, malignancy, or severe psychiatric disorders)
• Pregnancy or breastfeeding
• Life expectancy < 1 year
• Participation in another clinical trial that has not yet reached its primary endpoint
• Investigator judgment that the patient is non-compliant or unlikely to complete follow-up as required